Incisional Hernia After Midline LaparotomyPREEMPTNCT07753551
Prophylactic Mesh Reinforcement Versus Primary Closure After Emergency Midline Laparotomy (PREEMPT)
A study testing Prophylactic Biosynthetic Mesh Placement and Direct suture in people with Incisional Hernia After Midline Laparotomy and Emergency Abdominal Surgery, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
The PREEMPT trial is a multicenter randomized controlled trial comparing prophylactic onlay biosynthetic mesh reinforcement with primary suture closure in adult patients undergoing emergency midline laparotomy. Participants will be randomized in a 1:1 ratio. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia After Midline Laparotomy, Emergency Abdominal Surgery
- What is being tested?
- Prophylactic Biosynthetic Mesh Placement and Direct suture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to 31 Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients (≥18 years) undergoing emergency midline laparotomy will be eligible for inclusion, without upper age limit, to reflect real-world clinical practice.
Who cannot join
- Age < 18 years
- Minimally invasive surgery (laparoscopic or robotic approaches)
- Elective surgery
- Surgery requiring an open abdomen and its closure
- Fecal peritonitis
- Previous midline laparotomy
- Pregnancy or breastfeeding
- Conditions that would impair the possibility of understanding and giving of informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Andrea Divizia, MD, PhD contact
About this study
Official title: PRophylactic mEsh Reinforcement Versus Primary Closure After Emergency Midline Laparotomy (PREEMPT): A Multicenter Randomized Clinical Trial
The PREEMPT trial is a multicenter randomized controlled trial comparing prophylactic onlay biosynthetic mesh reinforcement with primary suture closure in adult patients undergoing emergency midline laparotomy. Participants will be randomized in a 1:1 ratio. The primary endpoint is the incidence of incisional hernia at 1 year. Secondary endpoints include postoperative complications, surgical site occurrences, pain, operative time, hospital stay, morbidity, mortality, quality of life, and long-term hernia incidence.
Read the detailed description
Incisional hernia (IH) is a frequent complication after midline laparotomy, with rates up to 50-70% in high-risk or emergency settings. Emergency procedures are particularly prone to IH due to contamination and suboptimal conditions. Prophylactic mesh reinforcement has been shown to significantly reduce IH rates in elective surgery without increasing wound morbidity, but evidence in emergency settings is scarce. Biosynthetic meshes, with favorable safety and cost profiles in contaminated fields, may offer an effective preventive strategy.
The PREEMPT trial is a multicenter, randomized (1:1) controlled study including adult patients undergoing emergency midline laparotomy. Eligible patients will be randomized to prophylactic onlay biosynthetic mesh reinforcement versus primary suture closure. The primary outcome is the incidence of incisional hernia at 1 year. Secondary outcomes include postoperative complications, surgical site occurrences, pain (VAS), operative time, length of hospital stay, 30-day morbidity and mortality, readmission and reoperation rates, and long-term quality of life (SF-36) and hernia incidence at 2 and 3 years.
The PREEMPT trial is a multicenter randomized clinical trial of patients undergoing emergency laparotomy. We aim to evaluate whether prophylactic bio-synthetic mesh reinforcement could reduce the incidence of incisional hernia in patients undergoing emergency midline laparotomy compared with primary suture closure.
- Being tested
- Prophylactic Biosynthetic Mesh Placement, Direct suture
- Keywords
- incisional hernia, laparotomy, emergency, primary prevention, surgical mesh
- Medical subject headings
- Incisional Hernia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic Biosynthetic Mesh PlacementDevice
A biosynthetic mesh (poly-4-hydroxybutyrate mesh) is placed prophylactically to reinforce abdominal wall closure during laparotomy closure.
Direct sutureProcedure or surgery
Direct fascial suture closure of the abdominal wall after laparotomy without prophylactic mesh reinforcement.
| Study group | Role | What they receive |
|---|---|---|
| Mesh-repair group | Experimental | Patients randomized to this arm will receive prophylactic onlay placement of a biosynthetic mesh (poly-4-hydroxybutyrate mesh) to reinforce the abdominal wall closure at the time of laparotomy closure, in addition to standard surgical closure. A minimum overlap of 3 cm on all sides of the incision will be ensured. Mesh fixation will be achieved with four sutures placed at the cardinal points only. Receives: Device: Prophylactic Biosynthetic Mesh Placement |
| Direct suture group | Active comparator | Patients randomized to this arm will receive standard abdominal wall closure according to European Hernia Society (EHS) guidelines: a slowly absorbable running suture will be used in all centers, employing a continuous small-bites technique. Tissue bites of 5-9 mm from the wound edges will incorporate the aponeurosis only, with stitches placed 5 mm apart to ensure uniform tension distribution, aiming for a suture length to wound length ratio of at least 4:1. Receives: Procedure: Direct suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of incisional hernia at 12 months after laparotomy
The primary outcome is the occurrence of incisional hernia within 12 months after laparotomy, assessed by clinical examination and/or imaging according to the study protocol. The incidence of incisional hernia will be compared between patients receiving prophylactic biosynthetic mesh reinforcement and patients undergoing standard abdominal wall closure without mesh.
Measured: 12 months after laparotomy
Secondary outcomes (5)
Postoperative complications
Postoperative complications will be assessed according to the Clavien-Dindo classification.
Measured: Within 30 days after surgery
Incidence of surgical site infection
The incidence of surgical site infection (superficial, deep, and organ-space infection) occurring after laparotomy will be evaluated and compared between treatment groups
Measured: Within 30 days after surgery
Incidence of surgical site occurrences after emergency laparotomy
The incidence of surgical site occurrences (SSO), including surgical site infection, seroma, wound dehiscence, hematoma, and other wound-related complications, will be assessed and compared between treatment groups.
Measured: Within 30 days after surgery
Incidence of surgical site occurrences requiring procedural intervention (SSOPI)
The incidence of surgical site occurrences requiring procedural intervention (SSOPI) will be assessed. SSOPI include surgical site occurrences requiring invasive treatment, such as wound drainage, percutaneous intervention, surgical debridement, or other procedural management.
Measured: Within 30 days after surgery
Incidence of incisional hernia at 2 and 3 years after surgery
The long-term incidence of incisional hernia will be assessed at 2 and 3 years after laparotomy and compared between patients receiving prophylactic biosynthetic mesh reinforcement and patients undergoing standard abdominal wall closure without mesh.
Measured: At 2 and 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Incisional Hernia After Midline LaparotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo, San Filippo Neri General Hospital, San Giovanni Addolorata Hospital, Santa Maria della Pieta Hospital - Nola, Buccheri La Ferla Hospital, Palermo, Cardarelli Hospital, Naples, Italy, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Responsible party
- Principal investigator, Andrea Divizia, University of Rome Tor Vergata
- Investigators
- Andrea Divizia, MD, PhD, Principal investigator, UOSD Chirurgia d'Urgenza, Policlinico di Roma Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753551
- Sponsor's protocol ID
- 58.26 CET2 PUD
- Acronym
- PREEMPT
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanders DL, Pawlak MM, Simons MP, Aufenacker T, Balla A, Berger C, Berrevoet F, de Beaux AC, East B, Henriksen NA, Klugar M, Langaufova A, Miserez M, Morales-Conde S, Montgomery A, Pettersson PK, Reinpold W, Renard Y, Slezakova S, Whitehead-Clarke T, Stabilini C. Midline incisional hernia guidelines: the European Hernia Society. Br J Surg. 2023 Nov 9;110(12):1732-1768. doi: 10.1093/bjs/znad284. No abstract available.
PubMed 37727928Lima HVG, Rasslan R, Novo FCF, Lima TMA, Damous SHB, Bernini CO, Montero EFS, Utiyama EM. Prevention of Fascial Dehiscence with Onlay Prophylactic Mesh in Emergency Laparotomy: A Randomized Clinical Trial. J Am Coll Surg. 2020 Jan;230(1):76-87. doi: 10.1016/j.jamcollsurg.2019.09.010. Epub 2019 Oct 28.
PubMed 31672681Ahmed J, Hasnain N, Fatima I, Malik F, Chaudhary MA, Ahmad J, Malik M, Malik L, Osama M, Baig MZ, Khosa F, Bhora F. Prophylactic Mesh Placement for the Prevention of Incisional Hernia in High-Risk Patients After Abdominal Surgery: A Systematic Review and Meta-Analysis. Cureus. 2020 Sep 16;12(9):e10491. doi: 10.7759/cureus.10491.
PubMed 32953367Rampado S, Geron A, Pirozzolo G, Ganss A, Pizzolato E, Bardini R. Cost analysis of incisional hernia repair with synthetic mesh and biological mesh: an Italian study. Updates Surg. 2017 Sep;69(3):375-381. doi: 10.1007/s13304-017-0453-9. Epub 2017 Apr 25.
PubMed 28444543Deerenberg EB, Henriksen NA, Antoniou GA, Antoniou SA, Bramer WM, Fischer JP, Fortelny RH, Gok H, Harris HW, Hope W, Horne CM, Jensen TK, Kockerling F, Kretschmer A, Lopez-Cano M, Malcher F, Shao JM, Slieker JC, de Smet GHJ, Stabilini C, Torkington J, Muysoms FE. Updated guideline for closure of abdominal wall incisions from the European and American Hernia Societies. Br J Surg. 2022 Nov 22;109(12):1239-1250. doi: 10.1093/bjs/znac302.
PubMed 36026550Rogmark P, Petersson U, Bringman S, Eklund A, Ezra E, Sevonius D, Smedberg S, Osterberg J, Montgomery A. Short-term outcomes for open and laparoscopic midline incisional hernia repair: a randomized multicenter controlled trial: the ProLOVE (prospective randomized trial on open versus laparoscopic operation of ventral eventrations) trial. Ann Surg. 2013 Jul;258(1):37-45. doi: 10.1097/SLA.0b013e31828fe1b2.
PubMed 23629524Langbach O, Bukholm I, Benth JS, Rokke O. Long-term quality of life and functionality after ventral hernia mesh repair. Surg Endosc. 2016 Nov;30(11):5023-5033. doi: 10.1007/s00464-016-4850-9. Epub 2016 Mar 11.
PubMed 26969665Dadashzadeh ER, Huckaby LV, Handzel R, Hossain MS, Sanin GD, Anto VP, Bou-Samra P, Moses JB, Cai S, Phelos HM, Simmons RL, Rosengart MR, van der Windt DJ. The Risk of Incarceration During Nonoperative Management of Incisional Hernias: A Population-based Analysis of 30,998 Patients. Ann Surg. 2022 Feb 1;275(2):e488-e495. doi: 10.1097/SLA.0000000000003916.
PubMed 32773624Argudo N, Pereira JA, Sancho JJ, Membrilla E, Pons MJ, Grande L. Prophylactic synthetic mesh can be safely used to close emergency laparotomies, even in peritonitis. Surgery. 2014 Nov;156(5):1238-44. doi: 10.1016/j.surg.2014.04.035. Epub 2014 Jul 10.
PubMed 25017136Depuydt M, Allaeys M, de Carvalho LA, Vanlander A, Berrevoet F. Prophylactic Mesh After Midline Laparotomy: Evidence is out There, but why do Surgeons Hesitate? World J Surg. 2021 May;45(5):1349-1361. doi: 10.1007/s00268-020-05898-0. Epub 2021 Feb 8.
PubMed 33558998Jairam AP, Lopez-Cano M, Garcia-Alamino JM, Pereira JA, Timmermans L, Jeekel J, Lange J, Muysoms F. Prevention of incisional hernia after midline laparotomy with prophylactic mesh reinforcement: a meta-analysis and trial sequential analysis. BJS Open. 2020 Jun;4(3):357-368. doi: 10.1002/bjs5.50261. Epub 2020 Feb 14.
PubMed 32057193Korenkov M, Paul A, Sauerland S, Neugebauer E, Arndt M, Chevrel JP, Corcione F, Fingerhut A, Flament JB, Kux M, Matzinger A, Myrvold HE, Rath AM, Simmermacher RK. Classification and surgical treatment of incisional hernia. Results of an experts' meeting. Langenbecks Arch Surg. 2001 Feb;386(1):65-73. doi: 10.1007/s004230000182.
PubMed 11405092
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRophylactic mEsh Reinforcement Versus Primary Closure After Emergency Midline Laparotomy (PREEMPT): A Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07753551
- Acronym / sponsor ID
- PREEMPT / 58.26 CET2 PUD
- Keywords
- incisional hernia, laparotomy, emergency, primary prevention, surgical mesh
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo, San Filippo Neri General Hospital, San Giovanni Addolorata Hospital, Santa Maria della Pieta Hospital - Nola, Buccheri La Ferla Hospital, Palermo, Cardarelli Hospital, Naples, Italy, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PREEMPT trial is a multicenter randomized controlled trial comparing prophylactic onlay biosynthetic mesh reinforcement with primary suture closure in adult patients undergoing emergency midline laparotomy. Participants will be randomized in a 1:1 ratio. The primary endpoint is the incidence of incisional hernia at 1 year. Secondary endpoints include postoperative complications, surgical site occurrences, pain, operative time, hospital stay, morbidity, mortality, quality of life, and long-term hernia incidence.
Detailed description
Incisional hernia (IH) is a frequent complication after midline laparotomy, with rates up to 50-70% in high-risk or emergency settings. Emergency procedures are particularly prone to IH due to contamination and suboptimal conditions. Prophylactic mesh reinforcement has been shown to significantly reduce IH rates in elective surgery without increasing wound morbidity, but evidence in emergency settings is scarce. Biosynthetic meshes, with favorable safety and cost profiles in contaminated fields, may offer an effective preventive strategy.
The PREEMPT trial is a multicenter, randomized (1:1) controlled study including adult patients undergoing emergency midline laparotomy. Eligible patients will be randomized to prophylactic onlay biosynthetic mesh reinforcement versus primary suture closure. The primary outcome is the incidence of incisional hernia at 1 year. Secondary outcomes include postoperative complications, surgical site occurrences, pain (VAS), operative time, length of hospital stay, 30-day morbidity and mortality, readmission and reoperation rates, and long-term quality of life (SF-36) and hernia incidence at 2 and 3 years.
The PREEMPT trial is a multicenter randomized clinical trial of patients undergoing emergency laparotomy. We aim to evaluate whether prophylactic bio-synthetic mesh reinforcement could reduce the incidence of incisional hernia in patients undergoing emergency midline laparotomy compared with primary suture closure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesh-repair group | Experimental | Device: Prophylactic Biosynthetic Mesh PlacementPatients randomized to this arm will receive prophylactic onlay placement of a biosynthetic mesh (poly-4-hydroxybutyrate mesh) to reinforce the abdominal wall closure at the time of laparotomy closure, in addition to standard surgical closure. A minimum overlap of 3 cm on all sides of the incision will be ensured. Mesh fixation will be achieved with four sutures placed at the cardinal points only. |
| Direct suture group | Active comparator | Procedure: Direct suturePatients randomized to this arm will receive standard abdominal wall closure according to European Hernia Society (EHS) guidelines: a slowly absorbable running suture will be used in all centers, employing a continuous small-bites technique. Tissue bites of 5-9 mm from the wound edges will incorporate the aponeurosis only, with stitches placed 5 mm apart to ensure uniform tension distribution, aiming for a suture length to wound length ratio of at least 4:1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients (≥18 years) undergoing emergency midline laparotomy will be eligible for inclusion, without upper age limit, to reflect real-world clinical practice.
Key exclusion criteria (8 listed)
- Age < 18 years
- Minimally invasive surgery (laparoscopic or robotic approaches)
- Elective surgery
- Surgery requiring an open abdomen and its closure
- Fecal peritonitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prophylactic Biosynthetic Mesh PlacementA biosynthetic mesh (poly-4-hydroxybutyrate mesh) is placed prophylactically to reinforce abdominal wall closure during laparotomy closure. | Device | Mesh-repair group |
| Direct sutureDirect fascial suture closure of the abdominal wall after laparotomy without prophylactic mesh reinforcement. | Procedure or surgery | Direct suture group |
Primary outcome
Incidence of incisional hernia at 12 months after laparotomy
Time frame: 12 months after laparotomy
The primary outcome is the occurrence of incisional hernia within 12 months after laparotomy, assessed by clinical examination and/or imaging according to the study protocol. The incidence of incisional hernia will be compared between patients receiving prophylactic biosynthetic mesh reinforcement and patients undergoing standard abdominal wall closure without mesh.
5 secondary outcomes
Postoperative complications
Time frame: Within 30 days after surgery
Incidence of surgical site infection
Time frame: Within 30 days after surgery
Incidence of surgical site occurrences after emergency laparotomy
Time frame: Within 30 days after surgery
Incidence of surgical site occurrences requiring procedural intervention (SSOPI)
Time frame: Within 30 days after surgery
Incidence of incisional hernia at 2 and 3 years after surgery
Time frame: At 2 and 3 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Background: PubMed 37727928Sanders DL, Pawlak MM, Simons MP, Aufenacker T, Balla A, Berger C, Berrevoet F, de Beaux AC, East B, Henriksen NA, Klugar M, Langaufova A, Miserez M, Morales-Conde S, Montgomery A, Pettersson PK, Reinpold W, Renard Y, Slezakova S, Whitehead-Clarke T, Stabilini C. Midline incisional hernia guidelines: the European Hernia Society. Br J Surg. 2023 Nov 9;110(12):1732-1768. doi: 10.1093/bjs/znad284. No abstract available.
- Background: PubMed 31672681Lima HVG, Rasslan R, Novo FCF, Lima TMA, Damous SHB, Bernini CO, Montero EFS, Utiyama EM. Prevention of Fascial Dehiscence with Onlay Prophylactic Mesh in Emergency Laparotomy: A Randomized Clinical Trial. J Am Coll Surg. 2020 Jan;230(1):76-87. doi: 10.1016/j.jamcollsurg.2019.09.010. Epub 2019 Oct 28.
- Background: PubMed 32953367Ahmed J, Hasnain N, Fatima I, Malik F, Chaudhary MA, Ahmad J, Malik M, Malik L, Osama M, Baig MZ, Khosa F, Bhora F. Prophylactic Mesh Placement for the Prevention of Incisional Hernia in High-Risk Patients After Abdominal Surgery: A Systematic Review and Meta-Analysis. Cureus. 2020 Sep 16;12(9):e10491. doi: 10.7759/cureus.10491.
- Background: PubMed 28444543Rampado S, Geron A, Pirozzolo G, Ganss A, Pizzolato E, Bardini R. Cost analysis of incisional hernia repair with synthetic mesh and biological mesh: an Italian study. Updates Surg. 2017 Sep;69(3):375-381. doi: 10.1007/s13304-017-0453-9. Epub 2017 Apr 25.
- Background: PubMed 36026550Deerenberg EB, Henriksen NA, Antoniou GA, Antoniou SA, Bramer WM, Fischer JP, Fortelny RH, Gok H, Harris HW, Hope W, Horne CM, Jensen TK, Kockerling F, Kretschmer A, Lopez-Cano M, Malcher F, Shao JM, Slieker JC, de Smet GHJ, Stabilini C, Torkington J, Muysoms FE. Updated guideline for closure of abdominal wall incisions from the European and American Hernia Societies. Br J Surg. 2022 Nov 22;109(12):1239-1250. doi: 10.1093/bjs/znac302.
- Background: PubMed 23629524Rogmark P, Petersson U, Bringman S, Eklund A, Ezra E, Sevonius D, Smedberg S, Osterberg J, Montgomery A. Short-term outcomes for open and laparoscopic midline incisional hernia repair: a randomized multicenter controlled trial: the ProLOVE (prospective randomized trial on open versus laparoscopic operation of ventral eventrations) trial. Ann Surg. 2013 Jul;258(1):37-45. doi: 10.1097/SLA.0b013e31828fe1b2.
- Background: PubMed 26969665Langbach O, Bukholm I, Benth JS, Rokke O. Long-term quality of life and functionality after ventral hernia mesh repair. Surg Endosc. 2016 Nov;30(11):5023-5033. doi: 10.1007/s00464-016-4850-9. Epub 2016 Mar 11.
- Background: PubMed 32773624Dadashzadeh ER, Huckaby LV, Handzel R, Hossain MS, Sanin GD, Anto VP, Bou-Samra P, Moses JB, Cai S, Phelos HM, Simmons RL, Rosengart MR, van der Windt DJ. The Risk of Incarceration During Nonoperative Management of Incisional Hernias: A Population-based Analysis of 30,998 Patients. Ann Surg. 2022 Feb 1;275(2):e488-e495. doi: 10.1097/SLA.0000000000003916.
- Background: PubMed 25017136Argudo N, Pereira JA, Sancho JJ, Membrilla E, Pons MJ, Grande L. Prophylactic synthetic mesh can be safely used to close emergency laparotomies, even in peritonitis. Surgery. 2014 Nov;156(5):1238-44. doi: 10.1016/j.surg.2014.04.035. Epub 2014 Jul 10.
- Background: PubMed 33558998Depuydt M, Allaeys M, de Carvalho LA, Vanlander A, Berrevoet F. Prophylactic Mesh After Midline Laparotomy: Evidence is out There, but why do Surgeons Hesitate? World J Surg. 2021 May;45(5):1349-1361. doi: 10.1007/s00268-020-05898-0. Epub 2021 Feb 8.
- Background: PubMed 32057193Jairam AP, Lopez-Cano M, Garcia-Alamino JM, Pereira JA, Timmermans L, Jeekel J, Lange J, Muysoms F. Prevention of incisional hernia after midline laparotomy with prophylactic mesh reinforcement: a meta-analysis and trial sequential analysis. BJS Open. 2020 Jun;4(3):357-368. doi: 10.1002/bjs5.50261. Epub 2020 Feb 14.
- Background: PubMed 11405092Korenkov M, Paul A, Sauerland S, Neugebauer E, Arndt M, Chevrel JP, Corcione F, Fingerhut A, Flament JB, Kux M, Matzinger A, Myrvold HE, Rath AM, Simmermacher RK. Classification and surgical treatment of incisional hernia. Results of an experts' meeting. Langenbecks Arch Surg. 2001 Feb;386(1):65-73. doi: 10.1007/s004230000182.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Divizia, MD, PhD contact
Andrea Divizia, MD, PhD principal investigator
UOSD Chirurgia d'Urgenza, Policlinico di Roma Tor Vergata
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic Biosynthetic Mesh Placement and Direct suture in people with Incisional Hernia After Midline Laparotomy and Emergency Abdominal Surgery, run by University of Rome Tor Vergata at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Martina Guida, MD (+390620908126, andreamartina.guida@ptvonline.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of incisional hernia at 12 months after laparotomy (time frame: 12 months after laparotomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07753551, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.